The biosimilar bevacizumab will be manufactured at its new multi-product monoclonal antibody (mAbs) drug substance facility in Bengaluru, the company said in a statement.
This approval will provide significant additional capacity to meet the needs of patients across all markets in Europe. The facility has previously received approval to manufacture biosimilar trastuzumab in September 2022.
Additionally, the facility also received Good Manufacturing Practice (GMP) compliance certificate by EMA, Biocon said.
GMP certification issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA was also granted to its insulin facility in Malaysia.
The GMP certification in India and Malaysia reflects Biocon Biologics' continued adherence to the highest standards of quality and our unwavering commitment to meeting the needs of patients globally, a company spokesperson said in a statement.
This approval will provide significant additional capacity to meet the needs of patients across all markets in Europe. The facility has previously received approval to manufacture biosimilar trastuzumab in September 2022.
Additionally, the facility also received Good Manufacturing Practice (GMP) compliance certificate by EMA, Biocon said.
GMP certification issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA was also granted to its insulin facility in Malaysia.
The GMP certification in India and Malaysia reflects Biocon Biologics' continued adherence to the highest standards of quality and our unwavering commitment to meeting the needs of patients globally, a company spokesperson said in a statement.
